Treatment of Mild Enteropathy Celiac Disease

Celiac Disease Clinical Trial

— TMCD  

Official title:

Treatment of Mild Enteropathy Celiac Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628823
• Other study ID #: SA-115376
• Status: Completed
• Phase: N/A
• First received: February 24, 2008
• Last updated: December 3, 2008
• Start date: March 2003
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

Description:

The current diagnostic criteria of celiac disease require small-bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). However, the mucosal damage develops gradually and the patients may have clinical symptoms and endomysial antibodies before the development of villous atrophy.

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. We hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Celiac disease suspicion

• Positive endomysial antibodies

• At least Marsh I -type small-bowel mucosal lesion

Exclusion Criteria:

• Earlier celiac disease diagnosis

• Consuming oral corticosteroids or immune suppressants

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease
• Intestinal Diseases

Intervention

Dietary Supplement:
• Gluten-free diet
Gluten containing foods removed from diet

Locations

Country	Name	City	State
Finland	University of Tampere	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
University of Tampere	Academy of Finland, University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small-Bowel mucosal morphology		one year	No
Secondary	Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.		One year	No